Rapid infuser with vacuum release valve

ABSTRACT

Presented herein is an infusate heating system with a vacuum release valve that obviates a system halt failure due to inaccurate detection of fluid level in an infusate reservoir.

BACKGROUND

To treat hemorrhaging (e.g., escape of blood from a ruptured vessel), itis often necessary to quickly infuse a substantial volume of fluid, e.g.whole blood, plasma or blood substitute, so as to maintain an adequateblood volume and circulation. However, to preserve blood or bloodproducts, such materials are typically refrigerated, and it is necessaryto warm them before infusion so as to avoid shock to a patient's system.While it is desired to heat the infusate quickly, the temperature of theinfusate should not exceed 40° C. to 42° C., since at highertemperatures, protein denaturation and red cell damage can occur. It isalso important that any electrical power or potentials utilized in theheating process be effectively isolated from a patient.

Furthermore, hyperthermia (e.g., an individual's body temperatureelevated above his or her normal range) as a treatment of tumors hasbeen carefully studied and applied. Research has shown that hightemperatures can damage cancer cells, usually without significant damageof normal tissues. Temperature and time may be interrelated with respectto tumor necrosis and risk of toxicity to normal cells. With longer timeat hyperthermia temperature, more tumor cells, as well as healthy cellsmay be damaged. Tumor cells may not efficiently dissipate heat due totheir disorganized and compact vascular structure; therefore,hyperthermia may cause the tumor cells to undergo apoptosis.

Hyperthermia may be particularly useful for reducing the risk ofmetastasis by targeting circulating tumor cells within the bloodstream.Cancerous cells may circulate within blood vessels (e.g., after surgicalremoval, cytoreduction surgery, de-bulking of tumor), attach toendothelial cells lining the blood vessels, and form secondary tumors ormetastatic lesions. However, a targeted treatment may not be possiblefor those circulating tumor cells. Hyperthermia via body cavities can beeffective in treating with circulating tumor cells. While healthy cells(e.g., non-tumor cells) may survive the treatment due to heat transferto the blood vessels, the floating tumor cells may not.

Fluid warmers often have a sensor connected to inflow tubing to detectif an infusate reservoir is empty. Typically, the sensor comprises atransmitter and a receiver (FIGS. 14A-14C), and measures velocity ofultrasound waves from the transmitter to distinguish between fluid andair, since ultrasound waves travel faster through fluids than air. Theinflow tubing is located between the transmitter and the receiver. Whenthe fluid level in the infusate reservoir is low (or zero), the pressurein the infusate reservoir and the inflow tubing can be lower than theatmospheric pressure. Therefore, the non-rigid inflow tubing deforms tominimize the pressure difference. The fluid out sensor measures thisdeformation.

The direction of deformation affects detectability by the sensor. Insome instances, e.g., where the major axis of the ellipticalcross-section of the collapsed inflow tubing is parallel to a linebetween the transmitter and the receiver, the sensor cannot detect thedeformation due to lack of air in the ultrasound beam path.

SUMMARY

The present disclosure provides improved technologies relating to amedical fluid heating apparatus. In certain embodiments, the presentinvention relates to an apparatus for heating a fluid and, moreparticularly, to an apparatus for quickly and controllably heating flowsof blood, or blood product, which may be needed for infusion into apatient, or flows of hyperthermia fluids, to induce tumor necrosis.

The new designs described herein solve problems associated with priorstrategies for heating infusate (e.g., blood, hyperthermia flood). Inparticular, the systems address a system halt failure due to inaccuratedetection of fluid level in a reservoir.

Embodiments of the present disclosure include new designs that do notexperience undesirable deformation of the inflow tubing which wouldundermine detectability by a fluid level sensor. In certain embodiments,the new design comprises a vacuum release valve, which supplies air tothe inflow tubing allowing fluid out detection caused by the presence ofair. The supplied air reduces the pressure difference between the inflowtubing and the atmosphere, thereby preventing the deformation of theinflow tubing and avoiding a possible failure to activate a system halt.

In one aspect, the invention directed to a system for heating a fluid,which comprises a conduit (e.g., toroid-shaped) defining a centralopening, a primary inductor at least partially within the centralopening, one or more secondary inductors within the conduit (e.g.,wherein each of the one or more secondary inductors is ring-shaped,flat), the conduit defining a central opening, an inflow tubingconnected to the conduit, and a vacuum release valve. In certainembodiments, each of the one or more secondary inductors issubstantially parallel. In certain embodiments, the secondary inductorsare separated by gaps (or spaces). In certain embodiments, the primaryinductor comprises a coil (or a winding). In certain embodiments, whenthe primary inductor is energized, the coil generates magnetic fluxpassing through the central opening. In certain embodiments, whenpressure in the inflow tubing is lower than atmospheric pressure, thevacuum release valve allows flow of air into the inflow tubing, therebyrapidly allowing the detection of a fluid out condition.

In certain embodiments, the system further comprises a reservoir forcontaining an infusate. In certain embodiments, the vacuum release valveis connected to the reservoir. In certain embodiments, the vacuumrelease valve is connected to the top of the reservoir. In certainembodiments, the vacuum release valve is connected to the bottom of thereservoir. In certain embodiments, the reservoir further comprises atubing attached to the top of the reservoir, and the vacuum releasevalve is connected to the reservoir through the tubing.

In certain embodiments, the vacuum release valve allows flow of air intothe inflow tubing when pressure in the inflow tubing is 1, 2, 3, 4, 5,6, 7, 8, 9, or 10 psi lower than atmospheric pressure.

In certain embodiments, the conduit provides a single fluid flow path.In certain embodiments, the single fluid flow path has a conformationsuch that fluid is not in contact with the primary inductor.

In certain embodiments, the system further comprises a fluid separatorcomprising an inlet nozzle and an outlet nozzle, wherein the inletnozzle directs an inlet flow to the conduit through the fluid separatorand the outlet nozzle receives an outlet flow from the conduit throughthe fluid separator.

In certain embodiments, the conduit comprises a plurality of spacerswhich provides the gaps between the secondary inductors.

In certain embodiments, wherein the one or more secondary inductorstransfers heat to fluid within the conduit.

In certain embodiments, the system further comprises a bubble trap forremoving air bubbles from fluid flowing through the system.

In another aspect, the invention directed to a disposable unit of asystem for heating a fluid, which comprises a conduit (e.g.,toroid-shaped) defining a central opening, one or more secondaryinductors within the conduit (e.g., wherein each of the one or moresecondary inductors is ring-shaped, flat), an inflow tubing connected tothe conduit, and a vacuum release valve. In certain embodiments, each ofthe one or more secondary inductors is substantially parallel.

In certain embodiments, the disposable unit further comprises areservoir for containing an infusate. In certain embodiments, the vacuumrelease valve is connected to the reservoir. In certain embodiments, thevacuum release valve is connected to the top of the reservoir. Incertain embodiments, the vacuum release valve is connected to the bottomof the reservoir. In certain embodiments, the reservoir furthercomprises a tubing attached to the top of the reservoir, and the vacuumrelease valve is connected to the reservoir through the tubing.

In certain embodiments, the disposable unit comprises a fluid separatorcomprising an inlet nozzle and an outlet nozzle. In certain embodiments,the conduit defines a single fluid flow path. In certain embodiments,the disposable unit further comprises a bubble trap for removing airbubbles from fluid flowing through the system.

A more complete understanding of the invention, as well as furtherfeatures and advantages thereof, will be obtained by reference to thefollowing detailed description read in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The Drawings, which are comprised of at least the following Figures, arefor illustration purposes only, not for limitation.

The foregoing and other objects, aspects, features, and advantages ofthe present disclosure may become more apparent and better understood byreferring to the following description taken in conduction with theaccompanying drawings, in which:

FIG. 1 is a schematic block diagram of a fluid heating apparatus,according to an illustrative embodiment of the present invention.

FIG. 2 is a front view of a disposable set, according to an embodimentof the instant invention.

FIG. 3 is a cross-sectional view of an inductive heater employed, shownwith a primary inductor, secondary inductors, a conduit, an inlet and anoutlet, according to an illustrative embodiment of the presentinvention.

FIG. 4 is a plan view, with parts broken away, of the heater of FIG. 3.

FIG. 5 illustrates a single flow path conduit with a fluid separatorcomprising an inlet nozzle and an outlet nozzle, according to anembodiment of the present invention.

FIGS. 6A-6G illustrate a fluid separator, according to an embodiment ofthe present invention.

FIGS. 7A and 7B are optical images of a fluid separator, according to anembodiment of the present invention.

FIG. 8 shows a part of a disposable set with a fluid separator, aconduit and a plurality of secondary inductors, according to anembodiment of the present invention.

FIGS. 9A-9E depict a spiral inductive tube, according to an embodimentof the present invention.

FIGS. 10A-10E depict a spiral inductive tube, according to otherembodiments of the present invention.

FIG. 11 shows a spiral inductive tube, according to an embodiment of thepresent invention.

FIG. 12 is a schematic representation of a slack time heating systemwith an associated disposable set, according to an embodiment of thepresent invention.

FIG. 13 is a schematic block diagram of circuitry for energizing theinductive heater of FIGS. 3 and 4.

FIGS. 14A-14C demonstrate a sensor for a fluid level in a reservoir, anddeformation of an inflow tubing.

FIG. 15A-15C depict exemplary disposable set with vacuum release valve,according to an embodiment of the present invention.

DEFINITIONS

In order for the present disclosure to be more readily understood,certain terms are first defined below. Additional definitions for thefollowing terms and other terms are set forth throughout thespecification.

As used herein, the term “administration” typically refers to theadministration of a composition to a subject or system. Those ofordinary skill in the art will be aware of a variety of routes that may,in appropriate circumstances, be utilized for administration to asubject, for example a human. For example, in certain embodiments,administration may be ocular, oral, parenteral, topical, etc. In someparticular embodiments, administration may be bronchial (e.g., bybronchial instillation), buccal, dermal (which may be or comprise, forexample, one or more of topical to the dermis, intradermal, interdermal,transdermal, etc.), enteral, intra-arterial, intradermal, intragastric,intramedullary, intramuscular, intranasal, intraperitoneal, intrathecal,intravenous, intraventricular, within a specific organ (e. g.intrahepatic), mucosal, nasal, oral, rectal, subcutaneous, sublingual,topical, tracheal (e.g., by intratracheal instillation), vaginal,vitreal, etc. In certain embodiments, administration may involve dosingthat is intermittent (e.g., a plurality of doses separated in time)and/or periodic (e.g., individual doses separated by a common period oftime) dosing. In certain embodiments, administration may involvecontinuous dosing (e.g., perfusion) for at least a selected period oftime.

As used herein, the term “approximately” or “about,” as applied to oneor more values of interest, refers to a value that is similar to astated reference value. In certain embodiments, the term “approximately”or “about” refers to a range of values that fall within 25%, 20%, 19%,18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%,2%, 1%, or less in either direction (greater than or less than) of thestated reference value unless otherwise stated or otherwise evident fromthe context (except where such number would exceed 100% of a possiblevalue).

The term “biocompatible”, as used herein, refers to materials that donot cause significant harm to living tissue when placed in contact withsuch tissue, e.g., in vivo. In certain embodiments, materials are“biocompatible” if they are not toxic to cells. In certain embodiments,materials are “biocompatible” if their addition to cells in vitroresults in less than or equal to 20% cell death, and/or theiradministration in vivo does not induce significant inflammation or othersuch adverse effects.

A composition or method described herein as “comprising” one or morenamed elements or steps is open-ended, meaning that the named elementsor steps are essential, but other elements or steps may be added withinthe scope of the composition or method. To avoid prolixity, it is alsounderstood that any composition or method described as “comprising” (orwhich “comprises”) one or more named elements or steps also describesthe corresponding, more limited composition or method “consistingessentially of” (or which “consists essentially of”) the same namedelements or steps, meaning that the composition or method includes thenamed essential elements or steps and may also include additionalelements or steps that do not materially affect the basic and novelcharacteristic(s) of the composition or method. It is also understoodthat any composition or method described herein as “comprising” or“consisting essentially of” one or more named elements or steps alsodescribes the corresponding, more limited, and closed-ended compositionor method “consisting of” (or “consists of”) the named elements or stepsto the exclusion of any other unnamed element or step. In anycomposition or method disclosed herein, known or disclosed equivalentsof any named essential element or step may be substituted for thatelement or step.

As used herein, the term “designed” refers to an agent (i) whosestructure is or was selected by the hand of man; (ii) that is producedby a process requiring the hand of man; and/or (iii) that is distinctfrom natural substances and other known agents.

As used herein, the term “low flow rate” refers to a non-zero (e.g., noless than 1 ml/min) flow rate less than about 100 ml/min, or less thanabout 50 ml/min, or less than about 40 ml/min, or less than about 30ml/min, or less than about 20 ml/min, or less than about 15 ml/min, orless than about 10 ml/min.

As used herein, the term “patient” refers to any organism to which aprovided composition is or may be administered, e.g., for experimental,diagnostic, prophylactic, cosmetic, and/or therapeutic purposes. Typicalpatients include animals (e.g., mammals such as mice, rats, rabbits,non-human primates, and/or humans). In certain embodiments, a patient isa human. In certain embodiments, a patient is suffering from orsusceptible to one or more disorders or conditions. In certainembodiments, a patient displays one or more symptoms of a disorder orcondition. In certain embodiments, a patient has been diagnosed with oneor more disorders or conditions. In certain embodiments, the disorder orcondition is or includes cancer, or presence of one or more tumors. Incertain embodiments, the patient is receiving or has received certaintherapy to diagnose and/or to treat a disease, disorder, or condition.

As used herein, the term “substantially” refers to the qualitativecondition of exhibiting total or near-total extent or degree of acharacteristic or property of interest.

As used herein, the term “treatment” (also “treat” or “treating”) refersto any administration of a therapy that partially or completelyalleviates, ameliorates, relives, inhibits, delays onset of, reducesseverity of, and/or reduces incidence of one or more symptoms, features,and/or causes of a particular disease, disorder, and/or condition. Incertain embodiments, such treatment may be of a subject who does notexhibit signs of the relevant disease, disorder and/or condition and/orof a subject who exhibits only early signs of the disease, disorder,and/or condition. Alternatively or additionally, such treatment may beof a subject who exhibits one or more established signs of the relevantdisease, disorder and/or condition. In certain embodiments, treatmentmay be of a subject who has been diagnosed as suffering from therelevant disease, disorder, and/or condition. In certain embodiments,treatment may be of a subject known to have one or more susceptibilityfactors that are statistically correlated with increased risk ofdevelopment of the relevant disease, disorder, and/or condition.

DETAILED DESCRIPTION

Throughout the description, where compositions are described as having,including, or comprising specific components, or where methods aredescribed as having, including, or comprising specific steps, it iscontemplated that, additionally, there are compositions of the presentinvention that consist essentially of, or consist of, the recitedcomponents, and that there are methods according to the presentinvention that consist essentially of, or consist of, the recitedprocessing steps.

It should be understood that the order of steps or order for performingcertain action is immaterial so long as the invention remains operable.Moreover, two or more steps or actions may be conducted simultaneously.

The following description is for illustration and exemplification of thedisclosure only, and is not intended to limit the invention to thespecific embodiments described.

The mention herein of any publication, for example, in the Backgroundsection, is not an admission that the publication serves as prior artwith respect to any of the claims presented herein. The Backgroundsection is presented for purposes of clarity and is not meant as adescription of prior art with respect to any claim.

As mentioned above, the present disclosure relates to warming of fluid(e.g., blood, blood products, hyperthermia fluid, and more). The presentdisclosure encompasses system, apparatus and/or methods of warmingfluids.

Most rapid fluid warmers utilize a relatively large water bath reservoirwhich is preheated to 39 to 40° C. Water is pumped rapidly through aheat exchanger through which the infusate is perfused, the two fluidstypically being separated by a thin, usually metallic, heat exchangesurface. These devices are relatively large and cumbersome due to theneed for the water bath and water pump, as well as a heat exchanger andassociated conduits. Such devices accordingly are not ideal for use inemergency situations.

Other rapid fluid warmers utilize resistive heating (i.e., Jouleheating) to increase temperature of the infusate. The resistive heatersare smaller than the heaters with the water bath, however, the resistiveheaters can encounter overheating the infusate. A local temperature ofthe resistive heaters can reach up to about 80° C., denaturing proteinsin the infusate.

Commercially available rapid fluid warmers are described in, forexample, U.S. Pat. Nos. 5,319,170, 6,175,688, 6,236,809, 6,480,257, and7,819,835.

Some blood warmers (e.g., the Belmont® Rapid Infuser, the Belmont®Hyperthermia Pump) utilize inductive or electro-magnetic heatingtechniques, involving a circular heat exchanger tailored to the shape ofthe magnetic field. Fluid is introduced into the toroid at a point wherethe fluid path bifurcates with each half flowing on opposites sides ofthe toroid, until the two halves rejoin at the fluid output of thetoroid. The electro-magnetic heater includes a primary inductor (coil),generating an alternating magnetic field. A high current density in thesecondary inductor converts electric energy into thermal energy, so thatthe secondary inductor provides heat to a fluid. This effective heatexchange system of the Belmont® Rapid Infuser enables fluid (e.g.,blood, blood products with temperature of 4 to 37.5° C.) to be heated toa target temperature (e.g., normothermia) in a single pass. Moreover, auser can control heat flux to the fluid precisely, thus, theelectro-magnetic heating system prevents overheating. Furthermore, sizeof the Belmont® Rapid Infuser and the Belmont® Hyperthermia Pump issignificantly smaller (e.g., IV-pole mountable) than other commercialfluid heaters.

Embodiments described herein address a problem that can sometimes arisewith toroidal heat exchangers with dual flow paths. At low flow rates,the pressure drop from the flow paths to the outlet may be insufficientto support flow through both paths, causing flow to occur on a singleside of the dual flow path, only. The other side of the dual flow path,therefore, encounters stagnant or slow flow. The stagnant or slow flowin a toroidal heat exchanger may be a concern, when blood or bloodproducts have either been improperly anticoagulated or have had theanticoagulant compromised (e.g., mixed with lactated Ringer's or othersolution containing calcium), clogs may occur. For example, if the bloodor blood product coagulate in one of the flow paths which has stagnantor slow flow, that flow path can become clogged. When the system withthe clogged flow path starts to supply heated fluids at a sufficientlyhigh rate (e.g., with an increased heat supply to the heat exchangers),the clogged flow path can become overheated due to insufficient supplyof fluids, which absorb heat from the heat exchangers (e.g., decreasethe temperature of the heat exchangers).

Embodiments of the present disclosure include new designs that provide asingle flow path without compromising advantages of the existing bloodwarmers, such that the heat exchanger would not experience stagnant flowthat may cause overheating of a local flow path. The single flow path isfound to obviate problems that may occur with the dual flow path systemdue to improper usage (e.g., use of blood or blood products that havenot been properly anticoagulated).

Fluid Heating System

In certain embodiments, as illustrated in FIGS. 1 and 2, a fluid heatingsystem comprises a reservoir of infusate (e.g., blood, plasma or othersolution). Fluid tubular lines and connectors of an infusion fluiddisposable set, for example, as described in FIG. 2, direct fluid toreservoirs of the infusion fluid disposable set. Additional tubularfluid lines and connectors of a disposable set direct fluid fromreservoirs to and through a heater. Infusate drawn from reservoir 11 isdriven by a pump 13 (e.g., roller pump) through an inductive heaterconstructed in accordance with the present disclosure. Heated fluid isdirected into a patient tubular fluid feed line to a patient's body.

In heater 15, infusate is brought to a preselected temperature; controlof the temperature is affected by feedback circuitry 21 and responds tooutlet temperature, e.g., as sensed by a temperature sensor 51 tocontrol the energization of an inductor, which effects the heatgeneration in the heater 15. This feedback circuitry is described ingreater detail below. From the heater 15, the infusate passes through aseparator 23, which removes all air and then passes to the patient.

In certain embodiments, as is illustrated in greater detail in FIGS. 3and 4, the heater 15 involves a conduit or housing 25, which may beconstructed of a suitable plastic material. A fluid separator 47provides an inlet 27 and an outlet 29, which are connected by aring-like annular chamber 31, which defines a single flow path with anopening 35. While the exemplary path is shown as forming a circle, itshould be understood that other shapes could also be used, e.g. ovoid.

A primary inductor comprising a winding 55 wound on a ferrite bobbincore 56 generates magnetic flux passing through the central opening andis inductively coupled to a plurality of secondary inductors 41A-41J forinducing local currents therein. The winding, however, does not surroundthe flow path. To improve the degree of coupling between the winding 55and the secondary inductors 41A-41J, ferrite magnetic end plates 57 and58 may be employed to extend the flux coverage.

Heat Exchanger

In certain embodiments, as illustrated in FIGS. 1 and 2, a fluid heatingsystem comprises a reservoir of infusate (e.g., blood, plasma or othersolution). Fluid tubular lines and connectors of an infusion fluiddisposable set, for example, as described in FIG. 2, direct fluid toreservoirs of the infusion fluid disposable set. Additional tubularfluid lines and connectors of a disposable set direct fluid fromreservoirs to and through a heater. Infusate drawn from reservoir 11 isdriven by a pump 13 (e.g., roller pump) through an inductive heaterconstructed in accordance with the present disclosure. Heated fluid isdirected into a patient tubular fluid feed line to a patient's body.

In heater 15, infusate is brought to a preselected temperature; controlof the temperature is affected by feedback circuitry 21 and responds tooutlet temperature, e.g., as sensed by a temperature sensor 51 tocontrol the energization of an inductor, which effects the heatgeneration in the heater 15. This feedback circuitry is described ingreater detail below. From the heater 15, the infusate passes through aseparator 23, which removes all air and then passes to the patient.

In certain embodiments, as is illustrated in greater detail in FIGS. 3and 4, the heater 15 involves a conduit or housing 25, which may beconstructed of a suitable plastic material. A fluid separator 47provides an inlet 27 and an outlet 29, which are connected by aring-like annular chamber 31, which defines a single flow path with anopening 35. While the exemplary path is shown as forming a circle, itshould be understood that other shapes could also be used, e.g. ovoid.

A primary inductor comprising a winding 55 wound on a ferrite bobbincore 56 generates magnetic flux passing through the central opening andis inductively coupled to a plurality of secondary inductors 41A-41J forinducing local currents therein. The winding, however, does not surroundthe flow path. To improve the degree of coupling between the winding 55and the secondary inductors 41A-41J, ferrite magnetic end plates 57 and58 may be employed to extend the flux coverage.

Heat Exchanger

In certain embodiments, the heat exchanger comprises thin or ribbon-likesecondary inductors 41A-41J) contained in a chamber 31. As illustrated,the secondary inductors have a circular ring-like shape. In alternativeembodiments, other shapes (e.g., beads) can be used. In certainembodiments, the secondary inductors extend generally parallel to eachother in a spaced relationship (spaced apart) with each secondaryinductor passing through the flow path so as to heat the fluid. As willbe apparent, fluid flowing from the inlet 27 to outlet 29 will passthrough the spaces between the secondary inductors 41A-41J and will bein intimate thermal contact therewith.

In certain embodiments, the chamber 31 is circular and the secondaryinductors 41A-41J are correspondingly formed as flat rings. This shapesimplifies obtaining symmetry and uniform heating. In other embodiments,other shapes are used. Spacing between adjacent secondary inductors41A-41J is maintained by spacers 43.

In certain embodiments, where amounts and/or properties of the fluids inthe heating system change, it is desirable to modify certain keyparameters of the heat exchanger. When a fluid is in contact with asolid surface, heat flux between the fluid and the solid surface, therate of heat energy transfers through the given surface per unit time,can be expressed as follows:

q=h·ΔT

wherein q is heat flux (W/m²), h is a heat transfer coefficient(W/m²·K), and ΔT is the difference in temperature between the solidsurface and surrounding fluid area (K). The heat transfer coefficient isa function of the key parameters, for example, conductivity of the solid(e.g., the secondary inductors), gaps between the secondary inductors,etc. Total heat transfer from the solid surface to the fluid can becalculated by multiplying total surface area to heat flux. Therefore,when one changes fluid to be heated and/or operating conditions, it maybe desirable to increase or decrease gaps between the secondaryinductors, increase or decrease the number of secondary conductors,change the total surface area of secondary inductors, and/or changematerials used in the construction of the secondary inductors. Forexample, in order to accommodate a higher heating capacity (e.g., higherflow rate), the number and/or the total surface area of the secondaryconductors may be increased.

In certain embodiments, the secondary inductors is constructed, forexample, of stainless steel. Other conductive materials such asconductive plastics might also be used. In certain embodiments, one ormore conductive materials are selected from the group consisting ofstainless steel, carbon (graphene), silver, copper, gold, aluminum,tungsten, zinc, nickel, lithium, iron, platinum, tin, carbon steel,lead, titanium, grain oriented electrical steel, manganin, constantan,mercury, nichrome, carbon (graphite) and combinations thereof. Incertain embodiments, one chooses less conductive material (e.g., highresistance) to generate increased dissipation heat in the secondaryinductors.

In certain embodiments, a conduit/chamber of the present disclosure hasat least 1, 2, 4, 6, 8, 10, 12, 14, 16, 18 or 20 secondary inductors.

In certain embodiments, each gap between secondary inductors has adistance of about 0.001″ to about 0.1″, about 0.001″ to about 0.1″,about 0.001″ to about 0.1″, or about 0.02″ to about 0.03″.

In certain embodiments, total surface area of secondary inductors isabout 1 to about 1000 in², about 1 to about 500 in², about 1 to about250 in², about 10 to about 1000 in², about 10 to about 500 in², or about10 to about 250 in².

Fluid Separator

In certain embodiments, a fluid separator is incorporated into a singleflow path heating system. The fluid separator may enable a single flowpath with minimal modification of the existing system (e.g., same theprimary inductor, tubing, etc.). An exemplary fluid separator isdepicted in FIGS. 6A-6G, 7A, 7B and 8. The fluid separator comprises aninlet nozzle and an outlet nozzle. The inlet nozzle 27 directs unheated(e.g., cold) fluid to the single flow path, while the outlet nozzle 29receives heated fluid from the single flow path. The inlet and outletnozzle are substantially parallel to each other to allow flow throughthe outlet nozzle in an opposite direction to flow through the inletnozzle.

In certain embodiments, the fluid separator has a housing. The housingprovides an inlet chamber and an outlet chamber in the fluid separator.The inlet (e.g., unheated) fluid first enters into the inlet chamber,and then moves into the single fluid path. The outlet (e.g., heated)fluid exits from the single fluid path, then passes through the outletchamber. Temperatures of the inlet fluid and outlet fluid can bemeasured at exterior walls of the inlet chamber and the outlet chamber,respectively. A portion of the housing is sufficientlythermally-conductive, so that the temperature of the fluid (e.g., inletunheated fluid, outlet heated fluid) is substantially identical to thetemperature of the housing (e.g., outside of the inlet chamber, theoutlet chamber) in contact with the fluid. In certain embodiments, thehousing comprise a notch that can secure a divider. In certainembodiments, the housing has two convex walls at the inlet chambers andthe outlet chambers, from the perspective of each of the inlet chamberand the outlet chamber as shown in FIGS. 6E and 6G. Temperature probesmay measure inlet and outlet temperatures at the convex walls.

In certain embodiments, a fluid separator comprises a divider separatingthe unheated fluid in the inlet chamber and the heated fluid in theoutlet chamber. The inlet nozzle 27 and the outlet nozzle 29 areconnected to different sections of the fluid separator, so that thedivider effectively separates the unheated fluid and the heated fluid.

The divider may have a solid upper portion to satisfactorily separatethe inlet chamber from the outlet chamber when the divider is secured inthe fluid separator. The divider may also have a lower portioncomprising a plurality of elongations 49 to accommodate a plurality ofsecondary inductors. For example, each elongation 49 may block each gapbetween the ring shaped secondary inductors 41A-41P, so that the dividerprevents mixing of the unheated fluid and the heated fluid between thesecondary inductors. In certain embodiments, each thickness of theelongations 49 are substantially identical to each gap between thesecondary inductors. In certain embodiments, the width of the notch andthe thickness of the divider are substantially identical, so that thenotch can secure the divider in the fluid separator.

In certain embodiments, the cross section of the inlet nozzle, where itis connected to the inlet chamber is semi-circular as shown in FIG. 6C.Similarly, the cross section of the outlet nozzle, where it is connectedto the outlet chamber may be semi-circular. The semi-circularcross-sections of the inlet and the outlet are located on opposite sidesof the fluid divider, so that the divider can separate the inlet and theoutlet when the divider is positioned therebetween.

In certain embodiments, the fluid separator is connected to theperipheral area of the conduit, as shown in FIG. 8, so that the inletnozzle and the outlet nozzle do not disturb alternating magnetic fieldscreated by the primary inductor.

In certain embodiments, seams between the divider and the housing aresealed. In certain embodiments, seams between the elongations of thedivider and the secondary inductors may be sealed. Adhesive may beapplied at seams and cured with ultraviolet light.

In certain embodiments, a fluid separator of the present disclosure isconstructed of insulating materials, for example, polymers and/orplastic so that the separator does not disturb the magnetic field in anyinstance.

Spiral Inductive Tube

In certain embodiments, a spiral inductive tube provides a single flowpath (e.g., instead of a fluid separator, a conduit, and secondaryinductors). Exemplary spiral inductive tubes are depicted in FIGS. 9A-9Eand 10A-10E. A tube (e.g., conductive tube) may be shaped into acircular form, creating the spiral inductive tube. The spiral tubecomprises one or more circular loops. The spiral tube may comprise oneor two extended tails, which can be connected to an inlet and/or outlet.The spiral tube may comprise a window for measuring temperature of thefluid flowing.

Similar to embodiments with thin ring-shaped secondary inductors, aprimary inductor may be inserted into a central opening of the spiralinductive tube, inductively coupling to the spiral inductive tube forgenerating local currents therein. An unheated fluid enters and flowswithin the spiral inductive tube, contacting the inner walls of thespiral inductive tube. Heat generated within the inductive walls of thespiral inductive tube (e.g., due to the alternating magnetic fields fromthe primary inductor) is transferred to the fluid in the spiralinductive tube.

In certain embodiments, the spiral inductive tube comprises one or moreconductive wires (e.g., copper) that electrically connect loops. Theconductive wires further provide electrical shorts within the spiralinductive tube.

In certain embodiments, the spiral inductive tube comprises aninsulating housing (e.g., polymer, plastic).

In certain embodiments, where amounts and/or properties of the fluids inthe heating system, it may be desirable to modify certain key parametersof the spiral inductive tube. For example, it is desirable to increaseor decrease inner and/or outer diameters of the spiral inductive tube,increase or decrease the number of windings, change the total surfacearea of the spiral inductive tube, and/or change materials used in theconstruction of the spiral inductive tube. For example, in order toaccommodate a higher heating capacity, the total surface area and/orwinding of the secondary conductors may be increased.

In certain embodiments, a spiral inductive tube is constructed of one ormore conductive materials selected from the group consisting ofstainless steel, carbon (graphene), silver, copper, gold, aluminum,tungsten, zinc, nickel, lithium, iron, platinum, tin, carbon steel,lead, titanium, grain oriented electrical steel, manganin, constantan,mercury, nichrome, carbon (graphite) and combinations thereof.

In certain embodiments, a spiral inductive tube has a total interiorsurface area of about 1 in² to about 1000 in², about 5 in² to about 1000in², about 10 in² to about 1000 in², about 1 in² to about 500 in², about1 in² to about 100 in², or about 1 in² to about 50 in².

In certain embodiments, an inner diameter of a spiral inductive tuberanges from about 1/32″ to about 1″, from about 1/16″ to about 1″, fromabout 1/32″ to about ½″, from about 1/32″ to about ¼″, or from about1/16″ to about ¼″.

In certain embodiments, a spiral inductive tube winds about 1 to about20 times, about 1 to about 10 times, or about 1 to about 5 times.

Operation

As indicated previously, the energy inductively coupled to the secondaryinductors 41A-41J or the spiral inductive tube is preferably controlledto maintain a preselected temperature at the outlet of the heater.Circuitry suitable for this purpose is illustrated in FIG. 13. Thesensor 51 provides an output signal corresponding to the temperature atthe outlet of the heater. This temperature signal is compared with areference voltage representing a desired temperature, e.g. 42° C., by anerror amplifier designated generally by reference character 63.

The error signal obtained from the error amplifier 63 is applied to amodulator 65 which modulates an amplitude cycle of a low frequencysignal obtained from a sine wave oscillator 66. The pulse width of thisamplitude modulated signal is in turn varied, as indicated at 67 using ahigh frequency signal obtained from an oscillator 71. This results in asignal or waveform having a high frequency carrier, but with an energycontent proportional to its low frequency amplitude. This signal is inturn applied through suitable driver circuitry 77 to a bridge type poweroutput circuit 79, which provides alternating current energization ofthe inductor winding 55.

As will be understood by those skilled in the art, power transferred tothe secondary inductors 41A-41J or the spiral inductive tube will bedetermined essentially by the average power content of the waveformapplied to the winding 55, thus, this power will be modulated inaccordance with an error signal such that the temperature at the outputof a heater is maintained at a value substantially equal to the desiredor set point temperature. Further, since the heat is generated in thesecondary inductors 41A-41J or the spiral inductive tube themselveswhich are in intimate thermal contact with the fluid passing through theheater, a very high overall efficiency is obtained. Further, since thevolume of fluid within the heater at any given moment is relativelysmall as compared with other devices, a relatively quick response isobtained and very little fluid is lost or unavailable to a patient,since the volume required to fill the system is correspondingly small.

In certain embodiments, an exemplary system of the present disclosurereceives electric power by an Alternating Current (AC) wall outlet. Incertain embodiments, the system is operated from battery power.

In certain embodiments, the system offers adjustability of flow rate ofa fluid from 1 ml/min to 2000 ml/min, or from 10 ml/min to 2000 ml/min.As discussed herein, the system obviates clogging problems that mayresult from low flow in dual flow path systems. Thus, the embodiments ofthe single flow path system described herein provide for advantageousoperation at low flow rates, e.g., non-zero flow rates of less thanabout 100 ml/min, or less than about 50 ml/min, or less than about 40ml/min, or less than about 30 ml/min, or less than about 20 ml/min, orless than about 15 ml/min, or less than about 10 ml/min.

In certain embodiments, an exemplary system of the present disclosurecomprises a bubble trap that separates air from fluid by gravitationalforce. For example, the bubble trap may have a chamber. Air introducedby a pump into a fluid may move to the top of the chamber, while theheated fluid exits from the bottom of the chamber.

Some part of the system needs to be disposable or replaceable from useto use. All of the electronics, energizing inductor and magnetic corescan be used repeatedly. In certain embodiments, a conduit is included aspart of a disposable set. In certain embodiments, secondary inductorsare included as part of a disposable set. In certain embodiments, afluid separator is included as part of a disposable set. In certainembodiments, a spiral inductive tube is included as part of a disposableset. In certain embodiments, a bubble trap is included as part of adisposable set. In certain embodiments, a housing is included as part ofa disposable set. In certain embodiments, a disposable set is for asingle use. A disposable set is constructed of materials that can besterilized and made pyrogen free by conventional methods and so thatsingle uses thereof are economically feasible.

In certain embodiments, components that the biological fluid (e.g.,blood) contacts are biocompatible and/or sterilizable or replaceable.

Slack Time Heating System

Administration of cold blood and other fluids at high flow rates (e.g.,greater than 500 ml/min, or greater than 750 ml per minute) using an inline warming system requires the delivery of high quantities of power tothe fluids. To infuse cold fluids at a rate in excess of these levelswould require more energy than the typical AC outlet can supply. Certainsystems store thermal energy in a separate fluid (e.g., water or oil,not infusate) for transferring the stored heat from the fluid to theinfusate during times of need. Drawbacks of this approach include thenecessity to later transfer energy to the infusate before/duringinfusion with the limited heat transfer rate of the system (e.g., due toa limited surface area between water/oil and infusate) and the potentialcontamination of the infusate by the fluid bath.

The present disclosure is directed to a slack-time heating system thatutilizes excess heating capacity of fluid heaters to pre-warm fluid in areservoir. The present disclosure describes a heating system to storeheat energy within a reservoir (e.g., in infusate) during off peakperiods (e.g., when low flow is required) for later use (e.g., when highflow is required).

FIG. 12 depicts an exemplary slack-time heating system. The systemcomprises a large volume reservoir 81 connected to a pump tubing 105threaded through a roller pump head further connected to a heatexchanger 87. The fluid path continues to a pressure chamber 89 and thendirects one path to a patient via a patient line 103 or back to thereservoir 81 via a recirculation line 97.

In certain embodiments, a slack-time heating system comprises adiversion valve 93 that controls the ratio between a flow in a patientline and a flow in a recirculation line. When the diversion valve is ina recirculation position (e.g., the patient line is obstructed, whilethe recirculation line is opened), the pump 107 will cause fluid in abubble trap to flow back to the reservoir (e.g., exit from the top).

In certain embodiments, reservoirs of the present disclosure mixunheated fluid and heated fluid.

In certain embodiments, the ratio of a flow in a patient line to a flowin a recirculation line is between 100:1 and 1:100.

In certain embodiments, the slack time heating system utilizes a singleflow path as described in the present disclosure.

Vacuum Release Vale

In certain embodiments, a fluid heating system has a sensor (e.g., fluidout sensor) 119 connected to an inflow tubing 121 (e.g., from aninfusate reservoir to fluid heaters) to detect if an infusate reservoiris empty. Typically, the sensor comprises a transmitter 123 and areceiver 125, and measures velocity of ultrasound (e.g., ultrasoundtravels faster through fluids than air) as shown in FIG. 14A. The inflowtubing 121 is located between the transmitter 123 and the receiver 125.When the fluid level in the infusate reservoir is low (or zero), thepressure in the infusate reservoir and the inflow tubing is lower thanthe atmospheric pressure. Therefore, the non-rigid inlet tubing 121deforms to minimize the pressure difference. For example, thecross-section area of the inlet tubing reduces, or the cross-section ofthe inflow tubing becomes elliptic, as shown in FIGS. 14B and 14C. Thesensor measures this deformation of the inflow tubing.

The direction of deformation affects detectability by the sensor. Forexample, a major axis of the elliptic cross-section can be perpendicularto a line between the transmitter and the receiver as shown in FIG. 14C,or parallel to that line as shown in FIG. 14B. If the major axis of theelliptic cross-section is not parallel (e.g., perpendicular) to the linebetween the transmitter and the receiver, the sensor can measure thedeformation properly as the ultrasound travels in air more than beforethe deformation. However, if the major axis of the ellipticcross-section is parallel to a line between the transmitter and thereceiver, the sensor cannot detect the deformation because of lack ofair in the ultrasound beam path.

The present disclosure is directed to a fluid heating system thatincludes a vacuum release valve to prevent the undesired orientation ofthe deformed inflow tubing. In certain embodiments, the vacuum releasevalve supply air to the tubing to reduce pressure difference between theinflow tubing and the surroundings, preventing the deformation of theinflow tubing.

FIGS. 15A-15C depict exemplary disposable sets with vacuum releasevalves. In certain embodiments, the vacuum release valve 127A isconnected on the bottom of the reservoir (FIG. 15A). The inflow tubingand the vacuum release valve may be parallel to each other. In certainembodiments, the vacuum release valve 127C is connected on the bottom ofthe reservoir (FIG. 15C). In certain embodiments, the vacuum releasevalve is indirectly connected to the reservoir. The reservoir maycomprise a tubing attached to the top of the reservoir (FIG. 15B). Thevacuum release valve may be connected to the reservoir through thetubing.

Any type of suitable vacuum release valve may be used in accordance withthe disclosure. The vacuum release valve may comprise a housing and aregulator. The vacuum release valve may operate automatically (e.g.,without an operator). The vacuum release valve is normally closed (e.g.,the vacuum release valve does not allow air into the inflow tubing,e.g., the regulator presses against a portion of the housing, therebyblocking air passage). When the pressure difference between the system(e.g., the reservoir, inflow tubing) and the atmosphere reaches apre-determined value (e.g., 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 psi),the vacuum release valve opens (e.g., the valve allows air to flow intothe system). The pre-determined value may be manipulated by varying anexternal force applied to the regulator. For example, if the pressuredifference between the system (e.g., the reservoir, inflow tubing) andthe atmosphere exceeds the applied force per area, the valve opens. Theforce may be applied mechanically (e.g., spring, diaphragm).

In certain embodiments, the vacuum release valve supplies air to thedisposable set when the pressure of the disposable set is about 0.5, 1,2, 3, 4, 5, 6, 7, 8, 9, or 10 psi lower than atmospheric pressure.

In certain embodiments, the vacuum release valve comprises a filter,and/or a sanitation unit to provide sterile air to the system.

In certain embodiments, a vacuum release valve is included as part of adisposable set.

EXEMPLIFICATION Single Flow Path

The present example describes, among other things, an exemplaryoperation of single flow path induction heater with an exemplary spiralinductive tube.

As shown in FIG. 11, aluminum tubing with an inner diameter of ⅛″ and anouter diameter of 3/16″ was shaped into a circular form to be operatedwithin the Belmont® Rapid Infuser by Belmont. Circular loops with 2.5overlapping turns and extended tails were created. Copper wire waswrapped around the input and output in order to provide electricalconnection with in the tubing. The tails are positioned in a fashion sothat the input and output thermal detectors are as close as possible tothe input and the output. The spiral inductive tube was successfullyinstalled in the Belmont® Rapid Infuser. The system pumped fluid throughthe tubing. Temperature of the outlet fluid was increased relative totemperature of the inlet fluid.

Vacuum Release Valve

The present example describes, among other things, exemplary operationsof a rapid heating system with exemplary vacuum release valves.

Disposable sets (e.g., The Belmont® 3-Spike Disposable Set) with variousvacuum release valves as shown in FIGS. 15A-15C were tested with theBelmont Rapid Infuser. A vacuum release valve was connected to the 4.4 Lreservoir (FIG. 15A), a y-connection at the intersection of tubing (FIG.15B), or onto the filter assembly (FIG. 15C). The modified disposablesets and the unmodified set were then tested. Testing mediums werewater, sodium chloride and water at 35.7 grams per 100 mL, and a 50/50mix of water and glycerin by volume. Each modified disposable set wastested at a wide range of flow rates. While the unmodified set wasclamped off as pressure decreased, the vacuum release valve of themodified sets allowed air to be drawn into the set, and did notexperience clamping off. Once the reservoir was sufficiently emptied,air would be drawn into the fluid path causing the fluid out detector toregister and the machine to turn off properly. The valve workedsuccessfully with all testing mediums and at any flow rate. The additionof the vacuum release valve prevented the improper deformation oftubing.

1. A system for heating a fluid, the system comprising: a conduitdefining a central opening; a primary inductor at least partially withinthe central opening; one or more secondary inductors within the conduit;an inflow tubing connected to the conduit; and a vacuum release valve,wherein each of the one or more secondary inductors is substantiallyparallel, the one or more secondary inductors being separated by gaps,wherein the primary inductor comprises a coil, wherein, when the primaryinductor is energized, the coil generates magnetic flux passing throughthe central opening, and wherein, when pressure in the inflow tubing islower than atmospheric pressure, the vacuum release valve allows flow ofair into the inflow tubing, thereby preventing deformation of the inflowtubing.
 2. The system of claim 1, further comprising a reservoir forcontaining an infusate.
 3. The system of claim 2, wherein the vacuumrelease valve is connected to the reservoir.
 4. The system of claim 3,wherein the vacuum release valve is connected to the top of thereservoir.
 5. The system of claim 3, wherein the vacuum release valve isconnected to the bottom of the reservoir.
 6. The system of claim 2,wherein the reservoir further comprises a tubing attached to the top ofthe reservoir, and the vacuum release valve is connected to thereservoir through the tubing.
 7. The system of claim 1, wherein thevacuum release valve allows flow of air into the inflow tubing whenpressure in the inflow tubing is 2 psi lower than atmospheric pressure.8. (canceled)
 9. The system of claim 1, wherein the conduit provides asingle fluid flow path.
 10. The system of claim 9, wherein the singlefluid flow path has a conformation such that fluid is not in contactwith the primary inductor.
 11. The system of claim 1, further comprisinga fluid separator comprising an inlet nozzle and an outlet nozzle,wherein the inlet nozzle directs an inlet flow to the conduit throughthe fluid separator and the outlet nozzle receives an outlet flow fromthe conduit through the fluid separator.
 12. The system of claim 1,wherein the conduit comprises a plurality of spacers which provides thegaps between the one or more secondary inductors.
 13. The system ofclaim 1, wherein the one or more secondary inductors transfers heat tofluid within the conduit.
 14. The system of claim 1, further comprisinga bubble trap for removing air bubbles from fluid flowing through thesystem.
 15. A disposable unit of a system for heating a fluid, thedisposable unit comprising: a conduit, defining a central opening; oneor more secondary inductors within the conduit; an inflow tubingconnected to the conduit; and a vacuum release valve; wherein each ofthe one or more secondary inductors is substantially parallel.
 16. Thedisposable unit of claim 15, further comprising a reservoir forcontaining an infusate.
 17. The disposable unit of claim 16, wherein thevacuum release valve is connected to the reservoir.
 18. The disposableunit of claim 17, wherein the vacuum release valve is connected to thetop of the reservoir.
 19. The disposable unit of claim 17, wherein thevacuum release valve is connected to the bottom of the reservoir. 20.The disposable unit of claim 16, wherein the reservoir further comprisesa tubing attached to the top of the reservoir, and the vacuum releasevalve is connected to the reservoir through the tubing.
 21. (canceled)22. The disposable unit of claim 15, further comprising a fluidseparator comprising an inlet nozzle and an outlet nozzle. 23.(canceled)
 24. The disposable unit of claim 15, further comprising abubble trap for removing air bubbles from fluid flowing through thesystem.